drugset / Trial / NCT00082537

MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)

NCT00082537

Phase 2 Completed 100 enrolled Merck Sharp & Dohme LLC
RandomizedSingle-groupDouble-blindTreatment

Summary

This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

Timeline

Start
2004-04
Primary completion
2006-10
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 3 mg/kg
Subject Caspofungin Other / unclassified 50 unknown

Indications